GMP Coordinator
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Måløv
Are you passionate about GMP, Quality and Production? Do you enjoy collaboration across departments and with different types of job profiles? Do you have the ability to set a clear direction while also motivating people to follow? If yes, you might be exactly the one we are looking for to join our department as a GMP Coordinator, apply today!
The Position As our new GMP Coordinator, you will be the department's quality responsible who sets the direction for the department's quality level. You will be a daily sparring partner regarding quality issues, and you will drive quality-related projects in the department. In this role you will lead and coordinate critical quality issues and compliance activities in the department and, if necessary, across departments. Your main responsibilities will be: Ensuring high-level GMP overview within department and proactive handling of quality challenges Supporting and challenging Deviations and Change requests Investigating, handling, and reporting deviations while using systematic problem solving Identifying and taking an active part in quality improvement across the department to achieve simplicity, alignment and/or build quality into the processes Updating and improving SOPs and job instructions Supporting and guiding junior colleagues wrt. GMP and quality Coordinating, preparing and presenting in audits and inspections You will be part of a network of other GMP coordinators in Oral Product Development (OPDev) where you will work with many exciting tasks across the area, such as collaborating with the management team to ensure our quality and training targets are met.
Qualifications We are looking for a GMP coordinator with a strong quality mindset who has the drive to set the direction for the department's quality and training level. To succeed in this role, you:
• Have a MSc in natural science, engineering or similar
• Have at least a couple years of experience from pharmaceutical industry or from other regulated areas
• Are familiar with complex quality processes and have experience from GMP-regulated areas
• Technical understanding of IT and systems, in relation to GMP, is an advantage
• Have strong communication skills and like to interact and collaborate with various stakeholders, across departments
• Are fully proficient in both Danish and English Experience with LEAN is an advantage, as it is an integral part of our everyday life. As a person you are able to communicate at all levels in the organization from technicians to QA and management. You are good at solving your tasks pragmatically, also by involving your key stakeholders. It is important that you can think and act with a broad and holistic perspective and see the big picture without losing sight of important details.
About the department Oral Product Development (OPDev) is part of the new area Emerging Technologies where we develop, document and supply solid dosage forms for clinical trials. OPDev is a relatively new organization that made history when we succeeded with the formulation of proteins in an oral platform – making the first GLP-1 tablet on the marked. In our department, Oral Pilot Plant, we are 35+ colleagues, organized in two teams. We are responsible for the manufacturing of oral products for phase 1 & 2 clinical trials. The department covers a broad range of process technologies for solid dosage forms, helping to bring the future to the patients. In our department we strive to continuously improve our way of working, testing things and changing things if necessary. We appreciate peoples’ differences and have an inclusive working environment where people are encouraged to share their opinions. We would love to welcome you as well! Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We are a dynamic company in an even more dynamic industry, and we know that what got us to where we are today, is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.
Contact For further information, please contact Associate Manager Annette Midtgaard Hvilsom +45 3079 3461 or QMS Partner Christina Frøkov +45 3075 8367
Deadline
08 November 2023. Please note that we will be reviewing applications on an ongoing basis, and we encourage you to apply as soon as possible.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
The Position As our new GMP Coordinator, you will be the department's quality responsible who sets the direction for the department's quality level. You will be a daily sparring partner regarding quality issues, and you will drive quality-related projects in the department. In this role you will lead and coordinate critical quality issues and compliance activities in the department and, if necessary, across departments. Your main responsibilities will be:
Qualifications We are looking for a GMP coordinator with a strong quality mindset who has the drive to set the direction for the department's quality and training level. To succeed in this role, you:
• Have a MSc in natural science, engineering or similar
• Have at least a couple years of experience from pharmaceutical industry or from other regulated areas
• Are familiar with complex quality processes and have experience from GMP-regulated areas
• Technical understanding of IT and systems, in relation to GMP, is an advantage
• Have strong communication skills and like to interact and collaborate with various stakeholders, across departments
• Are fully proficient in both Danish and English Experience with LEAN is an advantage, as it is an integral part of our everyday life. As a person you are able to communicate at all levels in the organization from technicians to QA and management. You are good at solving your tasks pragmatically, also by involving your key stakeholders. It is important that you can think and act with a broad and holistic perspective and see the big picture without losing sight of important details.
About the department Oral Product Development (OPDev) is part of the new area Emerging Technologies where we develop, document and supply solid dosage forms for clinical trials. OPDev is a relatively new organization that made history when we succeeded with the formulation of proteins in an oral platform – making the first GLP-1 tablet on the marked. In our department, Oral Pilot Plant, we are 35+ colleagues, organized in two teams. We are responsible for the manufacturing of oral products for phase 1 & 2 clinical trials. The department covers a broad range of process technologies for solid dosage forms, helping to bring the future to the patients. In our department we strive to continuously improve our way of working, testing things and changing things if necessary. We appreciate peoples’ differences and have an inclusive working environment where people are encouraged to share their opinions. We would love to welcome you as well! Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We are a dynamic company in an even more dynamic industry, and we know that what got us to where we are today, is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.
Contact For further information, please contact Associate Manager Annette Midtgaard Hvilsom +45 3079 3461 or QMS Partner Christina Frøkov +45 3075 8367
Deadline
08 November 2023. Please note that we will be reviewing applications on an ongoing basis, and we encourage you to apply as soon as possible.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Måløv.
Jobbet er oprettet på vores service den 14.9.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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